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A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Nivolumab+Palbociclib+Anastrozole (ANZ) | Experimental |
| |
| Arm B: Palbociclib+ANZ then Nivolumab+Palbociclib+ANZ | Experimental |
| |
| Arm C: Palbociclib+ANZ | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab | Biological | Specified Dose on Specified Days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Dose Limiting Toxicities (DLT) in the Safety Run-in Phase | The number of participants with dose limiting toxicities (DLTs) during the safety run-in phase. DLTS are defined as treatment emergent adverse events (TEAE) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 that occurs during the first 4 weeks (1 cycle) after treatment. Participants who withdraw from the study during the DLT evaluation period or have received less than 1 dose of nivolumab and 75% of accumulative doses of palbociclib of the cycle for reasons other than a DLT will not be considered as DLT-evaluable participants. | From first dose to 4 weeks after first dose |
| Residual Cancer Burden (RCB) 0-1 Rate in the Randomized Phase | RCB 0-I rate is defined as the percentage of randomized participants who achieve RCB 0: no residual disease or RCB-I: minimal residual disease. RCB is a continuous index combining pathological measurements of primary tumor (size and cellularity) and nodal metastases (number and size) defined by a point system at surgery. No participants continued to the randomized phase; trial was closed after completion of the Safety Run-in. | From randomization phase up to 5 treatment cycles (up to approximately 20 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per investigator radiographic assessment. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0031 | Whittier | California | 90603 | United States | ||
| University Cancer Blood Ctr |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Dose Level 1 | Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) |
| FG001 | Cohort 2: Dose Level 1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 13, 2020 | Jul 14, 2022 |
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| Anastrozole | Drug | Specified Dose on Specified Days |
|
| Palbociclib | Drug | Specified Dose on Specified Days |
|
| From first dose up to approximately 6 months after first dose |
| Breast Conserving Surgery (BCS) Rate | The percentage of participants who undergo breast conserving surgery (BCS) after completing the study treatments. Confidence interval based on the Clopper and Pearson method. | From first dose up to approximately 6 months after first dose |
| Pathological Complete Response (pCR) Rate | The percentage of participants with an absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. Confidence interval based on the Clopper and Pearson method. | From first dose up to approximately 6 months after first dose |
| The Number of Participants Experiencing Adverse Events (AEs) | The number of participants experiencing adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | From first dose to 30 days after last dose of study therapy (up to approximately 6 months) |
| The Number of Participants Experiencing Serious Adverse Events (SAEs) | The number of participants experiencing serious adverse events (SAEs). A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. | From first dose to 30 days after last dose of study therapy (up to approximately 6 months) |
| The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | The number of participants experiencing adverse events (AEs) that lead to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | From first dose to 30 days after last dose of study therapy (up to approximately 6 months) |
| The Number of Participants Experiencing Immune-Related Adverse Events (AEs) | The number of participants experiencing adverse events that are immune-related. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | From first dose to 100 days after last dose of study therapy (up to approximately 8 months) |
| The Number of Participants Deaths | The number of participants that have died during the study. | From first dose up to approximately 8 months |
| The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units | The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal | From first dose to 30 days after last dose of study therapy (up to approximately 6 months) |
| The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests | The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal | From first dose to 30 days after last dose of study therapy (up to approximately 6 months) |
| Athens |
| Georgia |
| 30607 |
| United States |
| Northside Hospital,Inc.- Central Research Department | Atlanta | Georgia | 30342 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Local Institution - 0041 | Florham Park | New Jersey | 07932 | United States |
| The Cancer Center At Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Hematology-Oncology Associates Of Fredricksburg, Inc | Fredericksburg | Virginia | 22408 | United States |
| Peninsula Cancer Institute | Newport News | Virginia | 23601 | United States |
| Local Institution - 0005 | Elizabeth Vale | South Australia | 5112 | Australia |
| Breast Cancer Research Centre - WA | Nedlands | Western Australia | 6009 | Australia |
| Local Institution - 0011 | Wilrijk | Antwerpen | 2610 | Belgium |
| Local Institution | Liège | 4000 | Belgium |
| Local Institution | Namur | 5000 | Belgium |
| Local Institution - 0071 | Ottawa | Ontario | K1H 8L6 | Canada |
| Local Institution - 0075 | Bordeaux | 33077 | France |
| Local Institution - 0073 | Créteil | 94010 | France |
| Local Institution - 0072 | La Roche-sur-Yon | 85925 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Local Institution - 0019 | Marseille | 13273 | France |
| Centre de Cancerologie du Grand Montpellier | Montpellier | 34070 | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| Local Institution | Bonn | 53111 | Germany |
| Local Institution | Erlangen | 91054 | Germany |
| Klinik Essen-Mitte | Essen | 45136 | Germany |
| Local Institution | Mönchengladbach | 41061 | Germany |
| Local Institution | Saarbrücken | 66113 | Germany |
| Local Institution - 0047 | Monterrey Ponce | 00731 | Puerto Rico |
| Local Institution - 0002 | San Juan | 00927 | Puerto Rico |
| Local Institution - 0062 | San Juan | 00936 | Puerto Rico |
| H. Univ. Vall dHebron | Barcelona | 08035 | Spain |
| Local Institution - 0037 | Barcelona | 08036 | Spain |
| Hosp Univer 12 De Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Virgen De La Victoria | Málaga | 29010 | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | 41013 | Spain |
| Hospital Clinico Universitario De Valencia | Valencia | 46010 | Spain |
Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) |
| FG002 | Cohort 2: Dose Level 2 | Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Dose Level 1 | Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) |
| BG001 | Cohort 2: Dose Level 1 | Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) |
| BG002 | Cohort 2: Dose Level 2 | Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants With Dose Limiting Toxicities (DLT) in the Safety Run-in Phase | The number of participants with dose limiting toxicities (DLTs) during the safety run-in phase. DLTS are defined as treatment emergent adverse events (TEAE) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 that occurs during the first 4 weeks (1 cycle) after treatment. Participants who withdraw from the study during the DLT evaluation period or have received less than 1 dose of nivolumab and 75% of accumulative doses of palbociclib of the cycle for reasons other than a DLT will not be considered as DLT-evaluable participants. | All DLT-evaluable participants | Posted | Count of Participants | Participants | From first dose to 4 weeks after first dose |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Residual Cancer Burden (RCB) 0-1 Rate in the Randomized Phase | RCB 0-I rate is defined as the percentage of randomized participants who achieve RCB 0: no residual disease or RCB-I: minimal residual disease. RCB is a continuous index combining pathological measurements of primary tumor (size and cellularity) and nodal metastases (number and size) defined by a point system at surgery. No participants continued to the randomized phase; trial was closed after completion of the Safety Run-in. | All randomized participants in the Randomized phase. | Posted | From randomization phase up to 5 treatment cycles (up to approximately 20 weeks) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per investigator radiographic assessment. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All Treated Participants in the Safety Run-in Phase | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose up to approximately 6 months after first dose |
| |||||||||||||||||||||||||||||||||
| Secondary | Breast Conserving Surgery (BCS) Rate | The percentage of participants who undergo breast conserving surgery (BCS) after completing the study treatments. Confidence interval based on the Clopper and Pearson method. | All Treated Participants in the Safety Run-In Phase | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose up to approximately 6 months after first dose |
| |||||||||||||||||||||||||||||||||
| Secondary | Pathological Complete Response (pCR) Rate | The percentage of participants with an absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. Confidence interval based on the Clopper and Pearson method. | All Treated Participants in the Safety Run-In Phase | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose up to approximately 6 months after first dose |
| |||||||||||||||||||||||||||||||||
| Secondary | The Number of Participants Experiencing Adverse Events (AEs) | The number of participants experiencing adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | All Treated Participants in the Safety Run-In Phase | Posted | Count of Participants | Participants | From first dose to 30 days after last dose of study therapy (up to approximately 6 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | The Number of Participants Experiencing Serious Adverse Events (SAEs) | The number of participants experiencing serious adverse events (SAEs). A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. | All Treated Participants in the Safety Run-In Phase | Posted | Count of Participants | Participants | From first dose to 30 days after last dose of study therapy (up to approximately 6 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | The number of participants experiencing adverse events (AEs) that lead to discontinuation of study treatment. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | All Treated Participants in the Safety Run-In Phase | Posted | Count of Participants | Participants | From first dose to 30 days after last dose of study therapy (up to approximately 6 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | The Number of Participants Experiencing Immune-Related Adverse Events (AEs) | The number of participants experiencing adverse events that are immune-related. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | All DLT-evaluable participants in the Safety Run-in Phase | Posted | Count of Participants | Participants | From first dose to 100 days after last dose of study therapy (up to approximately 8 months) |
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| Secondary | The Number of Participants Deaths | The number of participants that have died during the study. | All Treated Participants in the Safety Run-In Phase | Posted | Count of Participants | Participants | From first dose up to approximately 8 months |
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| Secondary | The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests - SI Units | The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal | All Treated Subjects in Safety Run-in Phase with at Least One On-Treatment TSH measurement | Posted | Count of Participants | Participants | From first dose to 30 days after last dose of study therapy (up to approximately 6 months) |
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| Secondary | The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests | The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase AST = Aspartate Aminotransferase ULN = Upper Limit of Normal | All Treated Participants in the Safety Run-in Phase | Posted | Count of Participants | Participants | From first dose to 30 days after last dose of study therapy (up to approximately 6 months) |
|
Adverse Events (AEs) were monitored from first dose to 100 days after last dose of study therapy (up to approximately 8 months). Serious Adverse events were monitored between first dose and 30 days after last dose of study therapy. (Up to approximately 6 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 21 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Dose Level 1 | Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Abemaciclib: 150 mg twice daily (BID) per os (by mouth) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) | 0 | 2 | 0 | 2 | 2 | 2 |
| EG001 | Cohort 2: Dose Level 1 | Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 125 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) | 0 | 9 | 5 | 9 | 8 | 9 |
| EG002 | Cohort 2: Dose Level 2 | Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) | 0 | 12 | 3 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | 24.1 | Systematic Assessment |
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| Hepatitis | Hepatobiliary disorders | 24.1 | Systematic Assessment |
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| Hypertransaminasaemia | Hepatobiliary disorders | 24.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 24.1 | Systematic Assessment |
| |
| Second primary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
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| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
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| Macrocytosis | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
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| Thrombocytosis | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | 24.1 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | 24.1 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | 24.1 | Systematic Assessment |
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| Ocular discomfort | Eye disorders | 24.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | 24.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | 24.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | 24.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | 24.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | 24.1 | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | 24.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | 24.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | 24.1 | Systematic Assessment |
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| Asthenia | General disorders | 24.1 | Systematic Assessment |
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| Axillary pain | General disorders | 24.1 | Systematic Assessment |
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| Fatigue | General disorders | 24.1 | Systematic Assessment |
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| Mucosal inflammation | General disorders | 24.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | 24.1 | Systematic Assessment |
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| Pyrexia | General disorders | 24.1 | Systematic Assessment |
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| Xerosis | General disorders | 24.1 | Systematic Assessment |
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| Hypertransaminasaemia | Hepatobiliary disorders | 24.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | 24.1 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | 24.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | 24.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | 24.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | 24.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
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| Viral infection | Infections and infestations | 24.1 | Systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
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| Radiation skin injury | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
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| Vascular access site pain | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | 24.1 | Systematic Assessment |
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| Amylase increased | Investigations | 24.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | 24.1 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | 24.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | 24.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | 24.1 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | 24.1 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | 24.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | 24.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | 24.1 | Systematic Assessment |
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| Transaminases increased | Investigations | 24.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | 24.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | 24.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | 24.1 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | 24.1 | Systematic Assessment |
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| Sinus headache | Nervous system disorders | 24.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | 24.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | 24.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | 24.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | 24.1 | Systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | 24.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | 24.1 | Systematic Assessment |
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Bristol Myers Squibb (BMS) decided to permanently discontinue enrollment and dosing in the nivolumab + abemaciclib + anastrozole cohorts during the Safety Run-in phase due to the risk of serious interstitial lung disease (ILD)/pneumonitis in patients receiving abemaciclib in combination with pembrolizumab. BMS decided to not move forward with the randomized phase of CA2097A8 and to close the trial after completion of the Safety Run-in.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 16, 2021 | Jul 14, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000077384 | Anastrozole |
| C500026 | palbociclib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >= 65 AND < 75 |
|
| >= 75 AND < 85 |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
|
| Cohort 2: Dose Level 2 |
Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) |
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Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks)
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|
Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) |
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Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) |
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Nivolumab: 480 mg every 4 weeks (Q4W) intravenously (IV) Palbociclib: 100 mg once daily (QD) per os (by mouth) for 3 weeks of each cycle (1 week off) Anastrozole: 1 mg once daily (QD) per os (by mouth) Participants will be treated for a maximum of 5 cycles (1 cycle = 4 weeks) |
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